BrainScope Announces FDA Clearance of the First Handheld Medical Device for Assessment of the Full Spectrum of Traumatic Brain Injury

Panel of Multi-Modal Capabilities Will Aid Physicians
With Their Clinical Diagnosis of Head-Injured Patients

Company's First Commercial Product, Ahead 300, To Be Introduced in Coming Months


BETHESDA, MD. September 26, 2016 – BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company to market the Ahead 300, its most advanced medical device for use in assessing traumatic brain injury (TBI). Developed in partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 represents an evolution from the three BrainScope products that have previously received FDA clearance, and with its substantial additional capabilities, will be the first product the company will sell commercially.

This Portable Brain Scanner Aims to Tell You Whether You Have a Concussion

By Aaron Gregg September 26 at 4:32 PM 

Concussions can be tough to diagnose. Figuring out whether a knock to the head significantly harmed a person’s brain usually requires a trip to the hospital and a potentially expensive MRI or CT scan.

BrainScope, a Bethesda-based biotech firm backed by AOL founder Steve Case, is working on a much easier way to do it: a wearable device that uses electrodes to measure electronic activity inside the brain and transmit readings to a reconfigured Android smartphone.

The company crossed a big hurdle when it announced Monday that it has received clearance from the Food and Drug Administration to market the device. The FDA action occurred last week.

The company wants to sell the scanner to hospitals and emergency rooms in the United States first, and chief executive Michael Singer said the product could one day expand to...


BETHESDA, MD - July 21, 2016 – BrainScope Company, Inc., a privately held neurotechnology company focusing on traumatic brain injury (TBI) and concussion assessment, announced today the appointment of Andrew Holman as Chief Commercial Officer. With over 20 years’ experience in sales and marketing in top echelon medical device companies, Holman will lead the commercialization efforts for BrainScope as it approaches the anticipated launch of its first product.

Holman most recently served as President of Corporate Development for Greatbatch, Inc., with prior roles as Chief Commercial Officer and Executive Vice President of Global Sales and Marketing.  During Holman’s tenure, Greatbatch exceeded market growth and completed a successful merger with Lake Region Medical, creating the largest medical device outsourcing organization in the world, now known as Integer Holdings Corporation.

Is This the Diagnostic Tool We’ve Been Waiting for in Concussion Testing?

A startup says its technology can serve as an objective concussion test. The challenge is convincing people it works.

By Mike Orcutt  MIT Technology Review - Biomedical

Concussion diagnosis is a notoriously tricky science.

Even if an assessment test on the sideline of a football or soccer field deems you to be concussion-free after a blow to the head, that doesn’t necessarily mean you didn’t suffer one, says Michael Singer, CEO of BrainScope, a Bethesda, Maryland-based company that has developed a new technology for detecting signs of a concussion in a person’s brain waves and has raised approximately


BETHESDA, MD – May 12, 2016 – BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, announced today that it received the Emerging Firm of the Year – Life Science Company Award by the Tech Council of Maryland (TCM). 

The award was presented Wednesday at TCM’s 28th Annual Industry Awards Celebration Dinner & Reception. The awards dinner is attended by over 800 executives from the life science and technology communities, and is Maryland’s largest and most prestigious award ceremony of its kind.  The criteria by which the award was judged included...


Dallas Hack, M.D., Col. (Ret.) and Geoffrey Ling, M.D., Ph.D., Col. (Ret.) Join BrainScope’s Scientific Advisory Board

 Bethesda, MD – April 19, 2016 – BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment announced today that Dallas Hack, M.D., Col. (Ret.) and Geoffrey Ling, M.D., Ph.D., Col. (Ret.) have joined BrainScope’s Scientific Advisory Board.


“We are deeply honored to have both Dr. Hack and Dr. Ling join our Scientific Advisory Board.  Their expertise in traumatic brain injury and concussion is unparalleled in the field, and we look forward to their important contributions to help foster the development of BrainScope’s objective medical devices for assessment across the spectrum of TBI,” stated Michael Singer, CEO of BrainScope.

BrainScope’s Objective Concussion Assessment Technology Showcased at NFL Annual Meeting

Boca Raton, FL. – March 22, 2016 – BrainScope Company Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, was one of a handful of companies featured at the NFL Annual Meeting today in Boca Raton, Fla. 

BrainScope’s technology appeared in the NFL’s “Vision 20/20 Tech Lab” along with a collection of new technologies that are helping to enhance the game of football for the players, coaches and fans across all levels of football.  

This brain-scanning headset knows when you have a concussion

Chris Weller

Super Bowl 50 is here, which means athletes will be trying harder than ever to deliver big hits.

A new medical device designed to identify traumatic brain injury (TBI) might not be far behind.

BrainScope is a one-two punch headset and mobile app that quickly and easily allows clinicians to determine whether patients have sustained a TBI.

It follows a growing body of research that tries to understand what head injuries look like and, more importantly, what clinicians can do about them so people stay safe.

Michael Singer, BrainScope's CEO, says many of the current techniques for evaluating someone's level of injury are flawed because they rely solely on symptoms.

If someone sustains a nasty hit, for example, they may complain about head pain — or they might not.

In the NFL, athletes are only required to take a baseline exam at the beginning of the season, called the ImPACT test. If they suffer a head injury, they take the test again to check for any fall off in their score. But even this standardized test has been found to yield false positives.

BrainScope cuts through that unreliable self-reported data to ...

Keep reading in TECH INSIDER »



Super Bowl 50: amid NFL's golden era, hints of a sweeping change


The Super Bowl shows the NFL is more popular than ever, but the game could change in fundamental ways because of mounting public concerns over head injuries. 

By Gloria Goodale, Staff writer FEBRUARY 6, 2016

David J. Phillip/AP

David J. Phillip/AP

A BrainScope device is displayed before an NFL health and safety news conference Thursday in San Francisco. The device can be used to help diagnose traumatic brain injuries. (AP Photo/ DAVID J. PHILLIP/AP

LOS ANGELES — National Football League news this week told two dramatically different stories.

On one hand, there was the run-up to the Super Bowl, with all the anticipation and intrigue around whether the Denver Broncos can stop the juggernaut that is Cam Newton and the Carolina Panthers.

Last year’s ratings for the game – a record 114.4 million viewers – suggest the NFL has never been more popular.

Yet there was also the story of Kenny Stabler, the late Oakland Raiders quarterback who was revealed to have been diagnosed with CTE, the degenerative brain condition linked to many former professional football players.

The contrast was both poignant and apt, many say.

At a time when the NFL is the unrivaled king of American professional sports, concerns about ...


Keep reading in The Christian Science Monitor »


NFL Shows off Technologies to prevent concussions at Moscone Center

As part of the lead up to Super Bowl 50 the National Football League is showing off technologies it is funding to help prevent concussions among players.

By Eric Thomas

Thursday, February 04, 2016 11:47PM


As part of the lead up to Super Bowl 50 the National Football League is showing off technologies it is funding to help prevent concussions among players.

The show was timely. A week after the NFL released numbers showing an almost 60 percent increase in reported concussions last season, they brought in medical experts to talk about it

"I believe very strongly that the NFL has an unmatched opportunity and platform to affect change when it comes to player health," said Betsy Nabel, the NFL's chief medical advisor.

The league showed off companies funded by something called the Head Health Initiative. These firms have used grants to come up with projects to try and protect players from head injury, like a helmet that uses special shock absorbing structure to reduce brain-rattling force.

"When you hit it gives a little bit, like a car bumper and redistributes the force," said Samuel Brown, a neurologist.

One strange looking invention tries to diagnose concussions by examining brain waves.

"We look at particular patterns within the brain and then use a sophisticated algorithm to decipher those patterns," said Michael Singer, the CEO of Brainscope.

The NFL has fought a public relations battle, with players filing suit saying they weren't told about the dangers. And even a big screen movie, "Concussion," about the doctor who first recognized concussions could lead to a deadly condition called CTE.

Retired players worry about what will happen to them.

"As a linebacker if you don't know that you're hitting people with your head and there could be a problem, I mean you're kind of crazy if you don't realize that," said Chris Draft, former NFL linebacker.

Even if these products prove effective there's still one thing scientists will have to deal with, the fact that players get bigger and stronger every year.

NFL quickie concussion-check on horizon?

By Scott Ostler

February 4, 2016

Photo: Scott Ostler

Hi-tech brain scanner can help detect concussions in a jiffy.

Is the NFL really trying to make its game safer and protect its players?

That’s the message the league seemed to be sending out at Thursday’s Health and Safety press conference at the Super Bowl media headquarters.

A couple of the innovations that were showcased, that might eventually show up on NFL football fields:

--A waffle-type cushion installed under artificial turf, to absorb shock and lessen trauma to bodies and heads. The cushioning doesn’t change the feel of the turf for the players and doesn’t affect cutting, running and jumping.

A rep of the Detroit company, Viconic, says the stuff is ready to roll and his company is talking to a few NFL teams, but no deals have been struck. The rep said fewer than 10 percent of synthetic-turf fields have any kind of cushioning.

--A brain-scan device (see photo) that gives an instant read-out of various brain functions, providing the sideline doctor with a more measureable and definitive diagnosis of head trauma. Was Joe Quarterback concussed? Just check the read-out.

Michael Singer of BrainScope says the device will be submitted soon for FDA approval and potentially could be available for use in the NFL next season.

Is the league really charging into a new era of player safety? We’ll see.

Scott Ostler is a San Francisco Chronicle columnist. E-mail: Twitter: @scottostler


Scott Ostler

Sports Columnist


BETHESDA, MD. November 23, 2015 – BrainScope Company, Inc., a privately held neurotechnology company with an initial focus on traumatic brain injury (TBI) and concussion assessment, announced today that Michael Singer, Chief Executive Officer, will present at the 27th Annual Piper Jaffray Healthcare Conference in New York City.  He is scheduled to present at 8:50 a.m. EST on Wednesday, December 2.

About BrainScope

BrainScope is a medical neurotechnology company that is developing a new generation of hand-held, easy-to-use, non-invasive instruments designed to aid medical professionals in rapidly and objectively assessing various neurological conditions.  The Company has received approximately $28 million of Department of Defense contracts and is backed by Revolution (created by AOL co-founder Steve Case), Shaman Ventures, ZG Ventures, State of Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors.  BrainScope's unique devices are being created to meet a long-standing clinical need for improved early identification and triage of head injured patients.  The Company holds 92 issued and pending patents on its technology.  In May 2015 the United States Food and Drug Administration (FDA) cleared the company’s Ahead 200 device, which uses commercial smartphone hardware leveraging Google’s Android operating system and a custom sensor to record and analyze a patient’s electroencephalogram (EEG) after head injury.  BrainScope devices under development, including the Ahead 300 and the Ahead Concussion Assessment System, for assessment of traumatically-induced structural head injury and concussion are for investigational use only.  For more information, please visit


In recent years, the National Football League has become more and more vigilant about prevention, assessment, and treatment of concussions and head injuries among players.

BrainScope, a Maryland neurotechnology company, recently received a $500,000 award from the NFL and General Electric to further develop the technology used in its portable products. BrainScope has produced several devices that use electrodes on the forehead to conduct and analyze an electroencephalogram, enabling medical professionals to assess brain injuries on the spot. Whether a player is injured on the... 

Keep reading in MDBIZ News »


Bethesda’s BrainScope scores $500k from NFL, General Electric

A Bethesda technology com­pany owned in part by Steve Case’s Rev­olution LLC gained yardage this week in its bid to help the National Football League and other sports organizations diagnose traumatic brain injuries.

BrainScope, which has 30 employees, announced Thursday that it received an additional $500,000 from the NFL and General Electric to keep working on its portable concussion-assessment system. The company is one of six finalists that the NFL and GE have chosen to fund...

Keep reading in Washington Post »


BETHESDA, MD. July 23, 2015 – BrainScope Company, Inc. today announced that it has received an additional $500,000 award from GE and the National Football League (NFL) to further enhance its portable concussion assessment system, as one of six final winners of the GE NFL Head Health Challenge I. In February 2014, Brainscope was selected as one of the initial 16 recipients from more than 400 entries from 27 countries of the up to $10 million Challenge, which was created by GE and the NFL to award entrants for proposals focusing on “identifying breakthrough technologies and approaches that will improve the diagnosis and prognosis of mild traumatic brain injury (TBI).”


BETHESDA, MD. May 18, 2015 – BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has cleared the company’s Ahead 200 device. Using commercial smartphone hardware that leverages Google’s Android operating system, the Ahead 200 records and analyzes a patient’s electroencephalograph (EEG) using a custom sensor attached to the handheld to provide an interpretation of the structural condition of the patient’s brain after head injury. In late 2012, BrainScope announced that it had been awarded a $2.67 million contract by the United States Army for development of the Ahead 200, a smaller, more rugged and modernized version of its Ahead 100 traumatic brain injury assessment technology. Similar to the Ahead 100, which was cleared this past November, it is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head Computerized Tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury (TBI), and are between the ages of 18-80 years.

BrainScope Announces Publication Demonstrating High Accuracy For Identification of Acute Stroke

BETHESDA, MD. January 6, 2015 – BrainScope Company, Inc. today announced the publication of an independent study that demonstrated the potential clinical utility of its Traumatic Brain Injury (TBI) technology to identify acute stroke in the hospital Emergency Department setting. The results of this study, “Identification of Acute Stroke Using Quantified Brain Electrical Activity” were published today in the peer-reviewed journal Academic Emergency Medicine authored by investigators from University Hospitals Case Medical Center, New York University School of Medicine, and The Johns Hopkins University School of Medicine. [...]